Heartware recalls PUMP 1104 HVAD implant kits with updated instructions for Controller Fault alarms and component lifespans to ensure safe use.
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Heartware is recalling specific PUMP 1104 HVAD implant kits to update instructions for handling Controller Fault alarms and component lifespans. This helps users understand when alarms occur and how long parts last, reducing confusion and potential risks.
The recall updates instructions for when Controller Fault alarms sound and how to troubleshoot them. It also clarifies the useful life of HVAD system components to prevent misunderstandings about part longevity.
Patients with Heartware PUMP 1104 HVAD implant kits (model 1104JP) are affected. Those with the listed serial numbers are most at risk.
Check for the model number 1104JP on the implant kit. Serial numbers listed in the recall include HW25172, HW25169FSCA, and many others starting with HW40000.
Read the new instructions for Controller Fault alarms and component lifespans provided by Heartware.
Heartware is updating instructions for Controller Fault alarms and component lifespans to improve clarity and safety.
No action is needed beyond reviewing the updated instructions for Controller Fault alarms and component lifespans.
Model 1104JP with serial numbers listed in the recall, including HW25172, HW25169FSCA, and many others starting with HW40000.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-0481-2024 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-0481-2024 from Heartware. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
